IRB Newsletter
Beneficence ∙ Respect for Persons ∙ Justice
IRB Approval Letters for NIH: We receive a number of requests each year for copies of IRB approval letters related to the “just in time” process. Unfortunately, many of these projects are covered (or not) under IRB approvals that have titles different from the title of the NIH grant about to be funded. From a regulatory perspective, it is always best to have titles of IRB and NIH protocols match. When requests are made for approval letters for studies with titles that differ from that of a grant application, the DHSP staff (Director, Associate Director, IRB chairs and vice chairs) must review the application to confirm that the work is covered under a specific IRB protocol and a memo generated to explain that to the granting agency.
To avoid this problem, please either submit a new completed IRB application having the same title as the grant or provide a memo to the DHSP indicating that the grant work is in fact covered by an existing IRB-approved study providing the titles of both the grant and the IRB protocol. If you are providing such a memo, attach the grant summary. DHSP will not provide a return memo to the PI or the ORA unless the grant summary is attached.
New IRB Forms: As part of the reaccreditation process for Jefferson’s Human Research Protection Program (HRPP), we have created some additional forms that will ensure that research conducted at Jefferson is in full compliance with federal human subjects regulations. These forms should be completed by a principal investigator when the research involves those issues covered in the forms.
The new forms are as follows:
· OHR-25 – This form allows the IRB to determine that federal criteria are met when approving research involving an investigational device. A prompt has been added to the OHR-2 regarding use of this form.
· OHR-26 – This form allows the IRB to determine that federal criteria are met when approving research involving children. Previously, the OHR-2 included an abbreviated version of this form. A prompt has been added to the OHR-2 regarding use of this form.
· OHR-27 – This form allows the IRB to determine that federal criteria are met when approving research involving pregnant women, human fetuses or neonates. A prompt has been added to the OHR-2 regarding use of this form.
· OHR-28 - This form allows the IRB to determine that federal criteria are met when approving research involving in vitro diagnostic devices.
All of these forms are now available on the IRB forms page at: http://www.jefferson.edu/human_research/irb/forms/index.cfm and are now in effect.
Also, the following two forms have been modified:
OHR-2 – Part H, #2, now asks if research will be conducted in states other than Pennsylvania and whether the research involves children. If yes to both, the investigator must provide state-specific information about who may serve as a LAR or guardian for a child to participate in research. The OHR-2 also asks the investigator to provide information about the state’s regulations pertaining to privacy and genetic research.
Parts C.II.8 & 9 expand on the IND exemption categories.
Part C.III directs the investigator to complete the OHR-25 & OHR-28 for investigational devices and in vitro diagnostic devices, respectively.
Part E directs investigator to complete OHR-26 for research involving children.
Part B, #7, directs investigator to complete OHR-27 for research involving pregnant women, fetuses, or neonates.
OHR-16 - #15 pertains to state-specific regulations regarding genetic research.
Review of Serious Adverse Events (AEs) and Unanticipated Problems Involving Risks to Subjects or Others (UAPs): We are now assessing whether a reported SAE was unexpected and therefore may represent a risk to participants or others, and whether the reported SAE may also constitute IRB non-compliance. An example of an SAE representing an UAP posing risk to the subject would be one that is not listed in the consent as a potential risk and is not related to underlying disease, but poses risk to the subject because of the severity, e.g., a pulmonary embolus. An example of an SAE that is a UAP posing risk to others might be development of pulmonary tuberculosis.
Likewise, when reviewing a UAP report (OHR-20 form), we are assessing whether the UAP may also represent IRB non-compliance. For example, an OHR-20 submitted because SAEs were either not reported or were reported weeks late would potentially represent IRB non-compliance.
Initial Review of allegation of possible non-compliance: When the Director or Associate Director of DHSP receives an allegation of possible IRB non-compliance, assessment of the allegation is made with respect to whether it represents non-compliance or an Unanticipated Problem Involving Risk to Subjects or Others (UAP). If it is non-compliance, a determination is made as to whether it is serious or continuing and, if so, further procedures according to TJU Policy 110.15 are initiated. If the allegation is also determined to be an UAP, an OHR-20 must be completed and reviewed by DHSP staff who confirm the UAP and assess the corrective action plan.
Compliance Corner:
§ Since the last Newsletter there have been no non-compliance issues.
Note: This and past issues of the IRB Newsletter can be accessed from the DHSP webpage - the link is in the box on the right side of the page.
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Published by:
The Division of Human Subjects Protection
Office of Human Research
Thomas Jefferson University
Editors: J. Bruce Smith, MD, CIP and Kyle Conner, MA, CIP
Assistant Editor: Kathleen Avender
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